Country: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
MOMETASONE FUROATE (UNII: 04201GDN4R) (MOMETASONE - UNII:8HR4QJ6DW8)
NORTHSTAR RX LLC
TOPICAL
PRESCRIPTION DRUG
Mometasone Furoate Cream USP, 0.1% contains mometasone furoate, USP for topical use. Mometasone furoate, USP is a synthetic corticosteroid with anti-inflammatory activity. Chemically, mometasone furoate, USP is 9α,21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the molecular formula C27 H30 Cl2 O6 , a molecular weight of 521.43 g/mol and the following structural formula: Mometasone furoate, USP is a white to off-white powder, soluble in acetone and methylene chloride. Each gram of Mometasone Furoate Cream USP, 0.1% contains: 1 mg mometasone furoate, USP in a cream base of aluminum starch octenyl succinate (Dry-Flo Plus (Pure)), hexylene glycol, phospholipon 90 H, phosphoric acid, purified water, titanium dioxide, white petrolatum, and white wax.
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Avoid excessive heat.
Abbreviated New Drug Application
MOMETASONE FUROATE- MOMETASONE FUROATE CREAM NORTHSTAR RX LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE MOMETASONE FUROATE CREAM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MOMETASONE FUROATE CREAM. MOMETASONE FUROATE CREAM, FOR TOPICAL USE INITIAL U.S. APPROVAL: 1987 INDICATIONS AND USAGE Mometasone furoate cream, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients ≥ 2 years of age. (1) DOSAGE AND ADMINISTRATION • • • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS Mometasone furoate cream, 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation. (4) WARNINGS AND PRECAUTIONS • • • ADVERSE REACTIONS Most common adverse reactions are: burning, pruritus, and skin atrophy. (6) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT NORTHSTAR RX LLC AT 1800-206-7821 OR FDA AT 1-800-FDA-1088 OR www.fda.gov/medwatch. SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT LABELING. REVISED: 2/2020 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Effects on Endocrine System Apply a thin film to the affected skin areas once daily. (2) Discontinue therapy when control is achieved. (2) If no improvement is seen within 2 weeks, reassess diagnosis. (2) Do not use with occlusive dressings unless directed by a physician. (2) Cream, 0.1%. (3) Reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment, Cushing’s syndrome, and hyperglycemia may occur due to systemic absorption. Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. Modify use should HPA axis suppression develop Aqra d-dokument sħiħ